Status and phase
Conditions
Treatments
About
This study is a phase I/II study of TJ011133 as Monotherapy and in Combination with Azacitidine (AZA) in Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). This study include Phase I and Phase IIa study. Phase I study ClinicalTrials.gov ID is NCT04202003 and this is for phase IIa study. Phase IIa study is designed to preliminarily assess the efficacy and safety of TJ011133 in combination with AZA as first-line treatment in patients with newly diagnosed AML who are intolerant to standard induction chemotherapy or patients with treatment naive, intermediate and high-risk MDS.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Phase 1 single dose escalation:
Male or female, aged ≥ 18 and ≤ 70 years at the time of signing informed consent form;
For the disease under study, enrollment may be considered if one of the following is satisfied:
For patients with MDS, a blast percentage of < 20% is required in bone marrow aspiration smear or bone marrow biopsy pathology at screening;
ECOG score 0-2;
Subjects have been recovered from the toxicity of previous anti-AML/MDS treatments (according to NCI CTC AE 5.0 ≤ Grade 1, except alopecia) ;
Subjects must have adequate liver function, renal function and coagulation function. The laboratory tests within 7 days before the first dose should meet the following requirements:
Liver function:
Renal function:
-Serum creatinine ≤ 1.5 × ULN or estimated creatinine clearance ≥ 50 mL/min according to the Cockcroft-Gault equation (Appendix 5).
Coagulation function:
Subjects for Phase 2a combination therapy:
Newly diagnosed AML with intolerance to standard induction chemotherapy/intermediate- and high-risk (International Prognostic Scoring System IPSS-R) MDS (only applicable for Phase 2a study); symptomatic treatment such as hydroxycarbamide, erythropoietin, and/or hematopoietic growth factors are allowed within 7 days of the first dose;
The subject's ECOG score has to meet the following criteria:
Newly diagnosed AML with intolerance to standard induction
Subjects must have adequate liver function, renal function and coagulation function. The laboratory tests within 7 days before the first dose should meet the following requirements::
Liver function:
Renal function:
-Estimated creatinine clearance ≥ 50 mL/min according to the Cockcroft-Gault equation (Appendix 5); creatinine clearance ≥ 30 mL/min is allowed for subjects aged 18 - 74 years (only for newly diagnosed AML subjects who are intolerant to standard induction chemotherapy)
Coagulation function:
All subjects:
Exclusion Criteria
Phase 1 single dose escalation:
Previously received treatment with other drug therapies targeting CD47;
Previously received CAR-T cell therapy;
Previously received treatment with PD1 or PDL1 antibody;
Previously received or planned to receive allogeneic stem cell transplantation during the study, or autologous stem cell transplantation within 3 months prior to the first dose of study drug;
Subjects have received chemotherapy, immunotherapy, radiotherapy, major surgery within 4 weeks prior to the first dose;
Subjects' cardiac function meet any of the following criteria:
Previously received treatment with demethylated drugs or cytotoxic drugs in patients with MDS;
Previously received any anti-tumor therapy for AML;
AML with a good prognosis, including cytogenetic alterations, such as t (8;21), inv (16) or t (16;16) or t (15;17);
Subjects are known to have allergy to AZA or mannitol;
Subjects' cardiac function meet any of the following criteria:
Subjects have undergone major surgery within 4 weeks prior to the first dose;
All subjects:
Primary purpose
Allocation
Interventional model
Masking
105 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal